FDAnews Device Daily Bulletin

Anti-fraud investigators may soon be taking a closer look at device clinical trials in an attempt to ensure that the safety and performance of devices reaching the market are supported by sound data, a government lawyer says.

American Optisurgical, an ophthalmic device company based in Lake Forest, Calif., received a 13-observation Form 483 after an inspection by Irvine, Calif., CDRH staff that stretched from Jan. 30 to Feb. 23.

The University of Rochester is combining its expertise in the health, engineering and business fields to create the new Center for Medical Technology Innovation.

Five years after first talking about a unique device identifier that medical device makers would need to put on most medical devices and packaging, the FDA is nearing the end of the comment period for its proposed rule.

Waltham devicemaker Respiratory Motion said it has received U.S. Food and Drug Administration approval for its respiration monitor.

TriVascular received premarket approval from the FDA for a stent system that treats abdominal aortic dissections.

According to analysts at Millennium Research Group, success in the Chinese medical device market depends on balancing risks such as the complex tendering process used by hospitals and the rise of domestic competitors against the real opportunities of this growing market.

Intuitive Surgical’s da Vinci surgical robot infringes at least one claim of a patent owned by Alisanos, according to a lawsuit.